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NCT01504841 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01504841: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01504841 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01504841, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is increasing, leading to treatment failure. This study tested the safety, tolerability, and dosing levels of etravirine (ETR), a new NNRTI.
Primary Outcome
Number (%) of participants who discontinued treatment due to a suspected adverse drug reaction (SADR) by Cohort.
Interventions
- DRUG Etravirine (ETR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-03-14 |
| Est. Completion | 2020-08-26 |
| Phase | Phase 1 |
What the finished NCT01504841 record still lists
NCT01504841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Etravirine (ETR) is the first listed.
NCT01504841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01504841 about?
NCT01504841 is a clinical study titled "Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children". Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is increasing, leading to treatment failure. This study tested the safety, tolerability, and dosing levels of etravirine (ETR), ...
What is the current status of trial NCT01504841?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-03-14. Estimated completion is 2020-08-26.
What interventions are being tested in trial NCT01504841?
The interventions under investigation include: Etravirine (ETR) (DRUG).
Who is sponsoring clinical trial NCT01504841?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01504841's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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